Commission Implementing Regulation (EU) 2019/1715 of 30 September 2019 laying down rules for the functioning of the information management system for official controls and its system components (the IMSOC Regulation) (Text with EEA relevance)

COMMISSION IMPLEMENTING REGULATION (EU) 2019/1715 of 30 September 2019 laying down rules for the functioning of the information management system for official controls and its system components (‘the IMSOC Regulation’) (Text with EEA relevance)

CHAPTER 1

Subject matter, scope and definitions

Article 1

Subject matter and scope

This Regulation lays down:

(a) specific conditions and procedures applicable to the transmission of notifications and supplementary information for the Rapid alert system for food and feed (RASFF) to be established pursuant to Regulation (EC) No 178/2002;

(b) procedures for the establishment and use of the computerised system for Union notification and reporting of diseases to be set up and managed by the Commission in accordance with Article 22 of Regulation (EU) 2016/429;

(c) specific rules, including deadlines, for the submission of notifications, to be laid down pursuant to Regulation (EU) 2016/2031;

(d) rules for the computerised handling and exchange of information, data and documents in the information management system for official controls (IMSOC) necessary for the performance of the official controls provided for in Regulation (EU) 2017/625, as regards: (i) the format of the common health entry document (CHED) referred to in Article 56 of Regulation (EU) 2017/625, including its electronic equivalent, and the instructions for its presentation and use; (ii) uniform arrangements for cooperation between customs authorities, competent authorities and other authorities, as referred to in Article 75 of Regulation (EU) 2017/625; (iii) the issuance of electronic certificates and the use of electronic signatures for the official certificates referred to in Article 87 of Regulation (EU) 2017/625; (iv) standard formats for information exchange in the framework of administrative assistance and cooperation, as referred to in Title IV of Regulation (EU) 2017/625, concerning: — requests for assistance, — common and recurrent notifications and responses; (v) specifications of the technical tools and procedures for communication between liaison bodies designated in accordance with Article 103(1) of Regulation (EU) 2017/625; (vi) the proper functioning of the IMSOC referred to in Chapter IV of Title VI of Regulation (EU) 2017/625.

Article 2

Definitions

For the purposes of this Regulation, the following definitions shall apply:

(1) ‘component’ means an electronic system integrated in the IMSOC;

(2) ‘network’ means a group of members having access to a specific component;

(3) ‘network member’ means a Member State’s competent authority, the Commission, an EU agency, a third country’s competent authority or an international organisation that has access to at least one component;

(4) ‘contact point’ means the contact point designated by the network member to represent it;

(5) ‘Member State’s national system’ means a computerised information system owned and set up before the date of entry into force of Regulation (EU) 2017/625 by a Member State for the purpose of managing, handling and exchanging data, information and documents on official controls, and capable of electronically exchanging data with the relevant component;

(6) ‘international organisation’ means any of the internationally recognised bodies listed in point (g) of Article 121 of Regulation (EU) 2017/625, or similar intergovernmental organisations;

(7) ‘iRASFF’ means the electronic system implementing the RASFF and AAC procedures described in Article 50 of Regulation (EC) No 178/2002 and Articles 102 to 108 of Regulation (EU) 2017/625 respectively;

(9) ‘RASFF network’ means the Rapid alert system established as a network by Article 50 of Regulation (EC) No 178/2002 for the notifications referred to in points (15) to (20) of this Article;

(10) ‘AAC network’ means the network composed of the Commission and the liaison bodies designated by the Member States in accordance with Article 103(1) of Regulation (EU) 2017/625 for the purpose of facilitating communication between competent authorities;

(11) ‘fraud network’ means the network composed of the Commission, Europol and the liaison bodies designated by the Member States in accordance with Article 103(1) of Regulation (EU) 2017/625 for the specific purpose of facilitating the exchange of information on fraud notifications as defined in point (21);

(12) ‘alert and cooperation network’ means a network composed of the RASFF, AAC and fraud networks;

(13) ‘single contact point’ means a contact point composed of the RASFF and AAC contact points in each Member State, whether or not physically located in the same administrative unit;

(14) ‘non-compliance notification’ means a notification in iRASFF of a non-compliance with the rules referred to in Article 1(2) of Regulation (EU) 2017/625 that does not represent a risk within the meaning of Article 50 of Regulation (EC) No 178/2002 and Article 29 of Regulation (EC) No 183/2005;

(15) ‘alert notification’ means a notification in iRASFF of a serious direct or indirect risk deriving from food, food contact material or feed within the meaning of Article 50 of Regulation (EC) No 178/2002 and Article 29 of Regulation (EC) No 183/2005 that requires or might require rapid action by another RASFF network member;

(16) ‘information notification’ means a notification in iRASFF of a direct or indirect risk deriving from food, food contact material or feed according to Article 50 of Regulation (EC) No 178/2002 and Article 29 of Regulation (EC) No 183/2005 that does not require rapid action by another RASFF network member;

(17) ‘information notification for follow-up’ means an information notification related to a product that is or may be placed on the market of another RASFF network member’s country;

(18) ‘information notification for attention’ means an information notification related to a product that: (i) either is present only in the notifying network member’s country; or (ii) has not been placed on the market; or (iii) is no longer on the market;

(19) ‘news notification’ means a notification in iRASFF concerning a risk deriving from food, food contact material or feed within the meaning of Article 50 of Regulation (EC) No 178/2002 and Article 29 of Regulation (EC) No 183/2005 that has an informal source, contains unverified information or concerns as yet an unidentified product;

(20) ‘border rejection notification’ means a notification in iRASFF of a rejection of a batch, container or cargo of food, food contact material or feed due to a risk as referred to in point (c) of the first subparagraph of Article 50(3) of Regulation (EC) No 178/2002 and Article 29 of Regulation (EC) No 183/2005;

(21) ‘fraud notification’ means a non-compliance notification in iRASFF concerning suspected intentional action by businesses or individuals for the purpose of deceiving purchasers and gaining undue advantage therefrom, in violation of the rules referred to in Article 1(2) of Regulation (EU) 2017/625;

(22) ‘original notification’ means a non-compliance notification, an alert notification, an information notification, a news notification, a fraud notification or a border rejection notification;

(23) ‘follow-up notification’ means a notification in iRASFF that contains additional information in relation to an original notification;

(24) ‘request’ means a request for administrative assistance in iRASFF based on an original or follow-up notification and enabling the exchange of information pursuant to Articles 104 to 108 of Regulation (EU) 2017/625;

(25) ‘response’ means a response to a request for administrative assistance in iRASFF based on an original or follow-up notification and enabling the exchange of information pursuant to Articles 104 to 108 of Regulation (EU) 2017/625;

(26) ‘notifying network member or contact point’ means the network member or contact point addressing a notification to another network member or contact point;

(27) ‘notified network member or contact point’ means the network member or contact point to which a notification is addressed by another network member or contact point;

(28) ‘requested network member or contact point’ means the network member or contact point to which a notification is addressed by another network member or contact point for the purpose of receiving a response;

(29) ‘ADIS’ means the computerised information system for the notification and reporting of diseases to be set up and managed by the Commission in accordance with Article 22 of Regulation (EU) 2016/429;

(30) ‘ADIS network’ means the network composed of the Commission and Member States’ competent authorities for the functioning of ADIS;

(31) ‘EUROPHYT’ means the electronic notification system to be established by the Commission and to be connected to, and compatible with, the IMSOC for Member States’ submission of EUROPHYT outbreak notifications in accordance with Article 103 of Regulation (EU) 2016/2031;

(32) ‘EUROPHYT outbreak notification’ means a notification to be submitted in EUROPHYT of any of the following: (a) the officially confirmed presence on the Union territory of a Union quarantine pest, as referred to in points (a) and (b) of the first paragraph of Article 11 of Regulation (EU) 2016/2031; (b) the officially confirmed presence of a pest not included in the list of Union quarantine pests, as referred to in Article 29(1) of Regulation (EU) 2016/2031; (c) the presence in, or the imminent danger of entry into, or spread within, the Union territory of a pest not included in the list of Union quarantine pests, as referred to in Article 30(1) of Regulation (EU) 2016/2031; (d) the officially confirmed presence of a protected zone quarantine pest, as referred to in Article 33(1) of Regulation (EU) 2016/2031;

(35) ‘EUROPHYT outbreak network’ means the network composed by the Commission and Member States’ competent authorities for the functioning of EUROPHYT;

(36) ‘TRACES’ means the computerised system referred to in Article 133(4) of Regulation (EU) 2017/625 for the purposes of exchanging data, information and documents;

(37) ‘TRACES network’ means the network composed by the Commission and Member States’ competent authorities for the functioning of TRACES;

(38) ‘electronic signature’ means an electronic signature as defined in point (10) of Article 3 of Regulation (EU) No 910/2014;

(39) ‘advanced electronic signature’ means an electronic signature complying with the technical specifications laid down in the Annex to Implementing Decision (EU) 2015/1506;

(40) ‘qualified electronic signature’ means an electronic signature as defined in point (12) of Article 3 of Regulation (EU) No 910/2014;

(41) ‘advanced electronic seal’ means an electronic seal complying with the technical specifications laid down in the Annex to Implementing Decision (EU) 2015/1506;

(42) ‘qualified electronic seal’ means an electronic seal as defined in point (27) of Article 3 of Regulation (EU) No 910/2014;

(43) ‘qualified electronic time stamp’ means an electronic time stamp as defined in point (34) of Article 3 of Regulation (EU) No 910/2014;

(44) ‘control point’ means a control point as referred to in point (a) of Article 53(1) of Regulation (EU) 2017/625;

(45) ‘control unit’ means a unit that has the technology and equipment necessary for the efficient operation of the relevant component and designated as follows for that purpose: (a) ‘central control unit’ for the central competent authority of a Member State; (b) ‘regional control unit’ for any regional competent authority of a Member State; (c) ‘local control unit’ for any local competent authority of a Member State.

CHAPTER 2

General principles and data protection

Article 3

IMSOC components

The IMSOC shall be composed of the following components:

(a) iRASFF;

(b) ADIS;

(c) EUROPHYT;

(d) TRACES.

Article 4

Components, networks and contact points

The Commission shall establish a governance structure to steer the development of, identify priorities for and monitor the correct implementation of the IMSOC. The governance structure shall be composed of:

(a) an operations management board, in collaboration with the Member States, to discuss, at least once a year, priorities for and the development of each component;

(b) sub-groups within the operations management board that regularly discuss priorities for and the development of specific functionalities of each component.

Article 5

Ownership and responsibilities for data, information and documents

Article 6

Links between components

Links between components shall be aimed at:

(a) complementing data, information or documents in one or more components by data, information or documents already present in another component; and

(b) providing relevant and up-to-date information to each network member for the performance of its tasks in accordance with the rules set for each component in this Regulation; and

(c) supporting and operating the procedures for (i) determining and modifying the frequency rates of identity checks and physical checks to be performed on consignments of categories of animals and goods referred to in points (a), (b) and (c) of Article 47(1) of Regulation (EU) 2017/625; (ii) applying the frequency of identity checks and physical checks to be performed on consignments of categories of animals or goods referred to in points (d), (e) and (f) of that Article; (iii) the coordinated performance by competent authorities of the intensified official controls in case of suspicions of non-compliance referred to in Article 65(6) of that Regulation.

The links referred to in paragraph 1 shall consist in links between:

(a) iRASFF and TRACES, allowing the exchange of data concerning border rejection notifications and common health entry documents;

(b) EUROPHYT and TRACES, allowing the exchange of data concerning EUROPHYT outbreak notifications;

(c) iRASFF and TRACES, allowing the exchange of data concerning operators’ past records as regards compliance with the rules referred to in Article 1(2) of Regulation (EU) 2017/625;

(d) ADIS and TRACES, allowing the exchange of data and information concerning Union notifications.

Article 7

Electronic data exchange between components and other electronic systems

Data exchanges between the IMSOC and other electronic systems, including the Member States’ national systems, shall:

(a) be based on international standards that are relevant for the component and use XML, CMS or PDF formats;

(b) use the specific data dictionaries and business rules provided for in the relevant component.

The Commission shall provide the Member States with:

(a) the frequency of identity checks and physical checks referred to in point (c)(i) of Article 6(1);

(b) the frequency rates and the outcome of the coordinated performance by competent authorities of the intensified official controls referred to in point (c)(iii) of Article 6(1);

(c) the data dictionaries and business rules referred to in point (b) of paragraph 1.

Article 8

Obligations and rights of the Commission

The Commission shall have access to all data, information and documents in each component in order to monitor the exchange of data, information and documents inserted or produced therein for identifying activities that are, or appear to be, not in compliance with the rules referred to in Article 1(2) of Regulation (EU) 2017/625, and:

(a) either have, or might have, ramifications in more than one Member State; or

(b) are, or appear to be, taking place in more than one Member State.

Article 9

Conditions for the granting of partial access to the IMSOC to third countries and international organisations

On receipt of a duly justified application, the Commission, in collaboration with the Member States, may grant the competent authority of a third country or an international organisation partial access to the functionalities of one or more components and to specific data, information and documents inserted or produced therein, provided the applicant demonstrates, in respect of the component(s) in question, that it meets the following requirements:

(a) it has the legal and operational capacity to provide, without undue delay, the assistance necessary to allow the good functioning of the component to which partial access is requested;

(b) it has designated a contact point for that purpose;

Article 10

Personal data processing

Personal data shall be processed in each component for the purpose of performing official controls and other official activities. In particular, personal data shall belong to one of the following categories:

(a) contact points, operators, importers, exporters, transporters and laboratory technicians when personal data is required by Union law;

(b) users of each component.

Article 11

Data controllers and joint controllership

The Commission shall be responsible for:

(a) determining and implementing the technical means to enable data subjects to exercise their rights, and ensuring that those rights are exercised in compliance with Regulation (EU) 2018/1725;

(b) ensuring the security of processing within each component pursuant to Article 33 of Regulation (EU) 2018/1725;

(c) determining the categories of its staff and external providers to whom access to the components may be granted;

(d) notifying and communicating any personal data breach of the components to the European Data Protection Supervisor pursuant to Article 34 of Regulation (EU) 2018/1725 and to the data subject pursuant to Article 35 of that Regulation respectively;

(e) ensuring that its staff and external providers are adequately trained to perform their tasks in accordance with Regulation (EU) 2018/1725.

The competent authorities of the Member States shall be responsible for:

(a) ensuring that data subject’s rights are exercised in compliance with Regulation (EU) 2016/679 and this Regulation;

(b) ensuring the security and confidentiality of personal data pursuant to Section 2 of Chapter IV of Regulation (EU) 2016/679;

(c) designating the staff that are to have access to each component;

(d) ensuring that staff accessing each component are adequately trained to perform their tasks in accordance with Regulation (EU) 2016/679 and, where relevant, Directive (EU) 2016/680.

CHAPTER 3

Components, networks and contact points

SECTION 1

iRASFF

Article 12

Liaison bodies responsible for the exchange of certain types of information

Member States shall indicate which of the liaison bodies designated in accordance with Article 103(1) of Regulation (EU) 2017/625 are responsible for exchanging information on fraud notifications.

Article 13

Single contact point

The single contact point in each Member State shall be responsible for:

(a) setting up effective arrangements for the smooth exchange of relevant information with all relevant competent authorities within its jurisdiction, allowing the immediate transmission of notifications, requests or responses to the competent authorities for appropriate action, and maintaining the notifications, requests or responses in good order;

(b) determining its roles and responsibilities and those of the relevant competent authorities within its jurisdiction as regards preparing and transmitting notifications, requests and responses, and assessing and distributing notifications, requests and responses from other members of the alert and cooperation network.

Article 14

Duties of the members of the alert and cooperation network

Article 15

Information exchanged in iRASFF

Article 16

Non-compliance notifications

Alert and cooperation network contact points shall exchange without undue delay non-compliance notifications including at least the following:

(a) the name of the competent authority dealing with the notification, if different from the contact point;

(b) a description of the possible non-compliance;

(c) the identification, where possible, of the operators associated with the possible non-compliance;

(d) details of the animals or goods involved;

(e) any information concerning suspected risks;

(f) an indication as to whether the notification relates to a possible instance of non-compliance perpetrated through fraudulent practices.

Article 17

Alert notifications

Article 18

Information notifications

Article 19

News notifications

Article 20

Border rejection notifications

Article 21

Fraud notifications

Fraud network contact points shall exchange fraud notifications including at least the following:

(a) all the information required by Article 16(1);

(b) a description of the suspected fraudulent practice;

(c) the identification, where possible, of the operators involved;

(d) information as to whether there are ongoing police or judicial investigations into the suspected fraudulent practice;

(e) information on any instructions from the police or judicial authorities as soon as they are available and can be disclosed.

Article 22

Follow-up notifications

Where the action referred to in paragraph 3 consists of detaining a product and returning to a dispatcher in the country of another RASFF network member:

(a) the network member taking the action shall provide relevant information about the returned product in a follow-up notification, unless that information was already included in full in the original notification;

(b) the other network member shall provide information in a follow-up notification on the action taken on the returned product.

Article 23

Access to iRASFF notifications

Article 24

Verification and publication of notifications

The Commission contact point’s verification of notifications shall cover:

(a) the completeness and legibility of the notification;

(b) the correctness of the legal basis supporting the notification; however an incorrect legal basis shall not prevent transmission of the notification if a risk has been identified;

(c) whether the notification falls within the scope of the RASFF network;

(d) whether the essential information in the notification is provided in a language that the alert and cooperation network contact point will easily understand;

(e) compliance with this Regulation;

(f) possible recurrences of the same operator and/or hazard and/or country of origin.

Article 25

Notification withdrawal and amendments

Where the action to be taken appears to be based on unfounded information or the notification was transmitted erroneously, any alert and cooperation network contact point may ask:

(a) a notifying contact point to withdraw a non-compliance, fraud or follow-up notification;

(b) the Commission contact point, with the agreement from the notifying contact point, to withdraw an alert, information, border rejection or news notification.

Article 26

Closure of a notification and storage period of personal data

A notification is automatically closed in iRASFF if:

(a) no follow-up requests are pending; or

(b) all requests have received a response; or

(c) no response to the last request is provided within 6 months of its transmission.

Article 27

Exchange of information with third countries

Article 28

Contingency arrangements for iRASFF

Where iRASFF is unavailable:

(a) the RASFF network contact points shall announce the transmission of an email concerning an alert notification or follow-up to an alert notification by a telephone call to the emergency phone number of the Commission contact point. The Commission contact point shall inform the RASFF network contact points required to follow-up by a telephone call to their emergency phone numbers;

(b) the AAC network contact points shall exchange information via email;

(c) the fraud network contact points shall exchange information on fraud notifications via email;

(d) the exchanges referred to in points (b) and (c) shall not trigger the request and response mechanism.

SECTION 2

ADIS

Article 29

ADIS network

Article 29a

Storage period of personal data

Personal data from Union notifications and Union reports referred to in Article 29(1) shall be stored in ADIS for no more than 10 years.

Article 29b

Contingency arrangements for ADIS

SECTION 3

EUROPHYT

Article 30

EUROPHYT outbreak network

Each EUROPHYT outbreak network member shall designate a contact point responsible for the submission of EUROPHYT outbreak notifications in EUROPHYT.

Article 32

Submission of EUROPHYT outbreak notifications to the EUROPHYT outbreak network

Article 34

Storage period of personal data for EUROPHYT outbreak notifications

EUROPHYT shall store personal data from EUROPHYT outbreak notifications for no more than 10 years.

SECTION 4

TRACES

Article 35

TRACES network

Without prejudice to Article 4(2), each TRACES network member shall designate one or more contact points for the functionalities provided for in Article 132(d) and Article 133 of Regulation (EU) 2017/625, and in other Union legislation referring to TRACES.

Article 36

Access to data, information and documents in TRACES

Article 37

Exchanges between TRACES and other electronic systems

Article 38

Cooperation between authorities in Member States in relation to consignments entering the Union

For the purpose of the cooperation provided for in Article 75(1) of Regulation (EU) 2017/625, the Member States’ customs authorities shall have access to data, information and documents relating to animals and goods entering the Union from third countries and to decisions taken on the basis of official controls carried out in accordance with Chapter V of Title II of that Regulation, through:

(a) TRACES or their Member States’ national systems; or

(b) the EU Single Window environment for customs based on the electronic customs systems referred to in Decision No 70/2008/EC and interconnected with TRACES.

Article 39

Issuance of electronic certificates for consignments of animals and goods entering the Union and use of electronic signatures

Electronic animal health certificates, official certificates and animal health/official certificates for consignments of animals and goods entering the Union shall meet all of the following requirements:

(a) they shall be issued in one of the following systems: (i) TRACES; (ii) a Member State’s national system; (iii) a third country’s or an international organisation’s electronic certification system that is capable of exchanging data with TRACES; (iv) a third country’s or an international organisation’s electronic certification system that is capable of exchanging data with a Member State’s national system;

(b) they shall be signed by an authorised officer with his/her electronic signature;

(c) they shall bear the advanced or qualified electronic seal of the issuing competent authority, or the advanced or qualified electronic signature of its legal representative.

Article 39a

Issuance of electronic certificates and commercial documents for movements of animals and goods between Member States and use of electronic signatures

Electronic animal health certificates, official certificates and animal health/official certificates for movements of animals, products of animal origin and germinal products between Member States, and electronic commercial documents for certain animal by-products and derived products, not intended for human consumption and transported to another Member State, shall meet all of the following requirements:

(a) they shall be issued in TRACES;

(b) they shall be signed by an official veterinarian or a certifying officer with his/her electronic signature;

(c) they shall bear the advanced or qualified electronic seal of the issuing competent authority.

Article 39b

Issuance of electronic certificates for export and re-export of plants, plant products and other objects and use of electronic signatures

Electronic phytosanitary certificates for export or re-export of plants, plant products and other objects from the Union territory to a third country shall be issued in one of the following systems:

(a) TRACES, provided that the certificate meets all of the following requirements: (i) it is signed by a certifying officer with his/her electronic signature; (ii) it bears the advanced or qualified electronic seal of the issuing competent authority;

(b) the national system of a Member State, provided that the certificate meets all of the following requirements: (i) it is signed by a certifying officer with his/her electronic signature; (ii) it is transmitted to TRACES at the latest at the time of electronic signature by the certifying officer and that transmission is sealed with the advanced or qualified electronic seal of the issuing competent authority.

Article 40

Format of the CHED and instructions for its presentation and use

The CHED shall contain entries for the information set out in Part 1 of Annex II to this Regulation and be used by the operator and the competent authorities in accordance with Article 56(3) of Regulation (EU) 2017/625 in one of the following formats, depending on the category of the consignment established in Article 47(1) of that Regulation:

(a) a CHED-A drawn up in accordance with the template in Section A of Part 2 of Annex II to this Regulation, for consignments of animals that are: (i) referred to in point (a) of Article 47(1) of Regulation (EU) 2017/625; or (ii) subject at their entry into the Union to measures provided for in points (e) or (f) of Article 47(1) of Regulation (EU) 2017/625;

(b) a CHED-P drawn up in accordance with the template in Section B of Part 2 of Annex II to this Regulation, for consignments of products that are: (i) referred to in point (b) of Article 47(1) of Regulation (EU) 2017/625; or (ii) subject at their entry into the Union to measures provided for in points (d), (e) or (f) of Article 47(1) of Regulation (EU) 2017/625;

(c) a CHED-PP drawn up in accordance with the template in Section C of Part 2 of Annex II to this Regulation, for consignments of: (i) plants, plant products and other objects referred to in point (c) of Article 47(1) of Regulation (EU) 2017/625; or (ii) plants, plant products and other objects subject at their entry into the Union to one of the measures or conditions provided for in points (d), (e) or (f) of Article 47(1) of Regulation (EU) 2017/625; or (iii) specific plants, plant products and other objects of a particular origin or provenance for which a minimum level of official controls is necessary to respond to recognised uniform hazards and risks to plant health as provided for in Implementing Regulation (EU) 2019/66;

(d) a CHED-D drawn up in accordance with the template in Section D of Part 2 of Annex II to this Regulation, for consignments of feed and food of non-animal origin subject at their entry into the Union to any of the measures or conditions provided for in points (d), (e) or (f) of Article 47(1) of Regulation (EU) 2017/625.

The CHED referred to in paragraph 1 shall be:

(a) drawn up in at least one of the official languages of the Member State of entry;

(b) duly completed in at least one of the official languages of the Member State of entry in accordance with the explanatory notes provided for in Part 1 of Annex II to this Regulation, by: (i) the operator responsible for the consignment, as regards the information on the details of the consignment, as described in Part I of the templates in Sections A to D of Part 2 of that Annex; (ii) the competent authority at a border control post or control point, as regards the information on the decision taken on the consignment, as described in Part II of the templates in Sections A to D of Part 2 of that Annex; (iii) the competent authority at the border control post of exit or final destination, or by the local competent authority, as regards the information on the follow-up measures taken on the consignment after a decision has been taken, as described in Part III of the templates in Sections A to D of Part 2 of that Annex.

Article 41

Use of an electronic CHED

An operator’s or a competent authority’s use of a CHED in an electronic format shall be by means of one of the following systems:

(a) TRACES, provided that the CHED meets all of the following requirements: (i) it is signed by the operator responsible for the consignment with his/her electronic signature; (ii) it is signed by the official veterinarian, the official plant health officer or the certifying officer at border control posts or control points with his/her electronic signature; (iii) it bears the advanced or qualified electronic seal of the issuing competent authority;

(b) the national system of a Member State, provided that the CHED meets all of the following requirements: (i) it is signed by the operator responsible for the consignment with his/her electronic signature; (ii) it is signed by the official veterinarian, the official plant health officer or the certifying officer at border control posts or control points with his/her electronic signature; (iii) it is transmitted to TRACES at the latest at the time when the decision on the consignment is taken on the basis of official controls and that transmission is sealed by the advanced or qualified electronic seal of the issuing competent authority.

Article 42

Periods of storage of electronic certificates and CHEDs and personal data therefrom

Article 43

List of control units

Each TRACES network contact point shall maintain and keep up to date in TRACES the list of control units that its Member State has designated for the purposes of TRACES.

Article 44

List of border control posts and control points

The contact point referred to in paragraph 1 of this Article shall insert in TRACES information regarding each designated border control post and control point using

(a) the format set out in Annex I to Commission Implementing Regulation (EU) 2019/1014 (²) to provide the information referred to in Article 60(1) of Regulation (EU) 2017/625;

(b) the abbreviations and specifications set out in Annex II to that Implementing Regulation.

Article 45

Lists of reference data

Each TRACES network contact point shall maintain and keep up to date in TRACES lists of the following:

(a) food business establishments that the competent authority of its Member State has approved in accordance with Article 6(3) of Regulation (EC) No 852/2004;

(b) establishments, plants and operators handling animal by-products or derived products that the competent authority of its Member State has approved or registered in accordance with Article 47 of Regulation (EC) No 1069/2009;

(c) control posts to which the competent authority of its Member State has granted an approval in accordance with Article 3 of Council Regulation (EC) No 1255/97 (³);

(d) transporters carrying out long journeys to which the competent authority has granted an authorisation pursuant to Article 11(1) of Council Regulation (EC) No 1/2005 (⁴);

(e) establishments included in the register of approved establishments referred to in point (b) of the first subparagraph of paragraph 1 of Article 101 of Regulation (EU) 2016/429 in so far as they move kept terrestrial animals and germinal products to another Member State or receive kept terrestrial animals and germinal products from a third country;

(f) establishments included in the register of approved aquaculture establishments and disease control aquatic food establishments referred to in respectively Article 185(1)(b) and (c) of Regulation (EU) 2016/429 in so far as they move aquaculture animals to another Member State or receive aquaculture animals from a third country;

(g) establishments and operators included in the register of registered establishments and operators referred to in point (a) of the first subparagraph of paragraph 1 of Article 101 of Regulation (EU) 2016/429 in so far as they move kept terrestrial animals and germinal products to another Member State or receive kept terrestrial animals and germinal products from a third country;

(h) establishments included in the register of registered aquaculture establishments referred to in Article 185(1)(a) of Regulation (EU) 2016/429 in so far as they move aquaculture animals to another Member State or receive aquaculture animals from a third country;

(i) transporters to which the competent authority has granted an authorisation pursuant to Article 10(1) of Regulation (EC) No 1/2005;

(j) drivers and attendants of road vehicles transporting domestic Equidae or domestic animals of bovine, ovine, caprine or porcine species or poultry to which the competent authority has granted a certificate of competence pursuant to Article 17(2) of Regulation (EC) No 1/2005;

(k) means of transport by road used for long journeys and livestock vessels to which the competent authority has granted a certificate of approval pursuant to respectively Articles 18(1) and 19(1) of Regulation (EC) No 1/2005;

(l) operators included in the register of professional operators introducing into the Union plants, plant products and other objects for which a phytosanitary certificate is required as referred to in point (a) of the first subparagraph of Article 65(1) of Regulation (EU) 2016/2031;

(m) quarantine stations and confinement facilities designated in accordance with Article 60 of Regulation (EU) 2016/2031 to carry out activities involving plants, plant products and other objects introduced into the Union territory from third countries.

Article 46

Contingency arrangements for TRACES and Member States’ national systems in the event of unplanned or planned unavailability

CHAPTER 4

Final provisions

Article 47

Repeals

Article 48

Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 14 December 2019, except for Section 2 of Chapter 3, which shall apply from 21 April 2021.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX I

Content of notifications referred to in Article 32

1.1.Title — enter the scientific name of the pest concerned, as referred to in points (a) and (b) of the first paragraph of Article 11, Article 29(1), Article 30(1) and Article 33(1) of Regulation (EU) 2016/2031, the location and whether it is first presence or not. The scientific name must be one of the following:

(1) the scientific name of the pest, including as appropriate the pathovar; or,

(2) if point (1) is not applicable, the scientific name approved by an international organisation, including the pathovar, and the name of that organisation; or,

(3) if neither point (1) nor point (2) is applicable, the scientific name from the most reliable source of information, with reference to that source.

You may submit explanatory notes.

1.2.Executive summary — a summary of the information in points 3 to 7.

1.3.Enter one of the following:

(1) partial notification in accordance with Article 32(1) and (2);

(2) notification in accordance with Article 32(3);

(3) update of notification in accordance with Article 32(4);

(4) closing note on the termination of measures and the reason for the termination.

2.1.Name of the single authority submitting the notification — enter the words ‘Notification from’, followed by the name of the single authority and its Member State.

2.2.Official contact at the single authority — enter the name, telephone number and email address of the person named by the single authority as official contact for the notification. Where more than one person is named, give the reasons.

3.1.Indicate, as precisely as possible, the location of the presence of the pest, with reference at least to an administrative region (e.g. municipality, city, province).

3.2.Attach one or more maps of the location.

4.1.Enter one of the following:

(1) first confirmed or suspected presence of the pest in the territory of the Member State concerned;

(2) confirmed or suspected presence of the pest in part of the territory of the Member State concerned, in which its presence was previously unknown. (Where applicable, indicate that the pest appeared in a part of the territory in which it had been previously present but was eradicated).

4.2.Pest status of the area (⁵) in which the pest has been found, after official confirmation — enter, with an explanatory note, one or more of the following:

(1) present in all parts of the area;

(2) present only in specific parts of the area;

(3) present in specific parts of the area where host plants are not grown;

(4) present: under eradication;

(5) present: under containment;

(6) present: at low prevalence;

(7) absent: pest found but eradicated;

(8) absent: pest found but no longer present for reasons other than eradication;

(9) transient (the presence of the pest is not expected to lead to establishment): non-actionable;

(10) transient: actionable, under surveillance;

(11) transient: actionable, under eradication;

(12) other.

4.3.Pest status in the Member State concerned before the official confirmation of the presence, or suspected presence, of the pest — enter with an explanatory note, one or more of the following:

(1) present in all parts of the Member State;

(2) present only in some parts of the Member State;

(3) present in specific parts of the Member State, where host crop(s) are not grown;

(4) present: seasonally;

(5) present: under eradication;

(6) present: under containment (where eradication is impossible);

(7) present: at low prevalence;

(8) absent: no pest records;

(9) absent: pest eradicated;

(10) absent: pest no longer present for reasons other than eradication;

(11) absent: pest records invalid;

(12) absent: pest records unreliable;

(13) absent: intercepted only;

(14) transient: non-actionable;

(15) transient: actionable, under surveillance;

(16) transient: actionable, under eradication;

(17) other.

4.4.Pest status in the Member State concerned after the official confirmation of the presence of the pest — enter, with an explanatory note, one or more of the following:

(1) present in all parts of the Member State;

(2) present only in some parts of the Member State;

(3) present in specific parts of the Member State where host crop(s) are not grown;

(4) present: seasonally;

(5) present: under eradication;

(6) present: under containment (where eradication is impossible);

(7) present: at low prevalence;

(8) absent: pest eradicated;

(9) absent: pest no longer present for reasons other than eradication;

(10) absent: pest records invalid;

(11) absent: pest records unreliable;

(12) absent: intercepted only;

(13) transient: non-actionable;

(14) transient: actionable, under surveillance;

(15) transient: actionable, under eradication;

(16) other.

5.1.How the presence of the pest was found or the suspicion of the presence arose — enter one of the following:

(1) pest-related official survey;

(2) survey relating to an existing or eradicated outbreak of a pest;

(3) phytosanitary inspections of any type;

(4) trace back and forward inspection relating to the specific presence of the pest;

(5) official inspection for other than phytosanitary purposes;

(6) information submitted by professional operators, laboratories or others;

(7) scientific information;

(8) other.

You may make further comments in the form of free text or attached documents.

If you enter option (8), indicate a specification.

For inspections, indicate the date(s), the description of the method (including details of visual or other checks), briefly describe the site of the inspection and the findings, and provide picture(s).

If you enter option (3) or (4), indicate the date of inspection(s) and describe the method of inspection (including details of visual or other checks). You may briefly describe the site of the inspection and the findings, and provide picture(s).

5.2.Date of finding — enter the date on which the responsible official body established the presence of the pest, began to suspect it or was first informed of its finding. If the pest was found by a person other than the responsible official body, enter the date on which it was found and on which that person informed the responsible official body.

5.3.Sampling for laboratory analysis — where applicable, provide information on the sampling procedure for laboratory analysis, including date, method and sample size. You may attach pictures.

5.4.Laboratory — where applicable, enter the name and the address of the laboratory(ies) involved in identifying the pest.

5.5.Diagnostic method — enter one of the following:

(1) according to peer reviewed protocol — (provide a clear reference to the protocol and, where appropriate, any deviation from it).

(2) other (specify the method).

5.6.Date of official confirmation of the identity of the pest.

6.1.Size and delimitation of the infested area — enter one or more of the following (you may give approximate figures, but explain why it is not possible to be precise):

(1) infested surface (m², ha, km²);

(2) number of infested plants (pieces);

(3) volume of infested plant products (tons, m³);

(4) GPS key coordinates or other specific description (e.g. Eurostat territorial units (NUTS), geographical codes (Geocodes), aerial photos) delimitating the area.

6.2.Characteristics of the infested area and its vicinity — enter one or more of the following:

(1) Open air — production area: (1.1) field (arable, pasture); (1.2) orchard/vineyard; (1.3) nursery; (1.4) forest.

(2) Open air — other: (2.1) private garden; (2.2) public sites; (2.3) conservation area; (2.4) wild plants in areas other than conservation areas; (2.5) other (please specify).

(3) physically closed conditions: (3.1) greenhouse; (3.2) other conservatories; (3.3) private site (other than greenhouse); (3.4) public site (other than greenhouse); (3.5) other (please specify).

For each option, indicate whether the infestation concerns one or more of the following:

— plants for planting;

— other plants;

— plant products; or

— other objects.

6.3.Host plants in the infested area and its vicinity — give the scientific name of host plants in that area, in accordance with point 6.4. You may provide additional information on the density of host plants, with reference to cultivation practices specific characteristic of the habitats, or on susceptible plant products produced in the area.

6.4.Infested plant(s), plant product(s) and other object(s) — give the scientific name of the infested host plant(s). You may indicate the variety and, for plant products, the type of the commodity, as appropriate.

6.5.Vectors present in the area — where applicable, enter one of the following:

(1) the scientific name of the vectors at least at genus level; or,

(2) if point (1) is not applicable, the scientific name approved by an international organisation and the name of that organisation(s); or,

(3) if neither point (1) nor point (2) is applicable, the scientific name from the most reliable source of information, with reference to that source. You may provide additional information on the density of the vectors or characteristics of plants important for the vectors.

6.6.Severity of the outbreak — describe the current extent of infestation, symptoms and damage. Where appropriate, include forecasts as soon as they are available.

6.7.Source of the outbreak — indicate the confirmed pathway of the pest into the area or of the suspected pathway pending confirmation, as applicable. You may provide further information concerning the confirmed or potential origin of the pest.

7.1.Adoption of official phytosanitary measures — enter one of the following options and provide explanatory notes:

(1) official phytosanitary measures have been taken in the form of chemical, biological or physical treatment.

(2) official phytosanitary measures, other than measures in the form of chemical, biological or physical treatment, have been taken.

(3) official phytosanitary measures will be taken.

(4) a decision on official phytosanitary measures is pending;

(5) no official phytosanitary measures (explain why).

Where a demarcated area has been established, indicate under options (1), (2) and (3) whether the measures have been/will be taken in or outside that area.

7.2.Date of adoption of official phytosanitary measures (indicate the expected duration of any temporary measures).

7.3.Identification of the area covered by official phytosanitary measures — indicate the method used to identify the area covered by official phytosanitary measures. Provide the results of the surveys that have been carried out.

7.4.Objective of the official phytosanitary measures — enter one of the following options:

(1) eradication;

(2) containment (where eradication is impossible).

7.5.Measures affecting the movement of goods — enter one of the following options:

(1) measures affect the import of goods into the Union or the movement of goods within the Union (please describe the measures);

(2) measures do not affect the import of goods into the Union or the movement of goods within the Union.

7.6.Specific surveys — where surveys are carried out as part of official phytosanitary measures, describe their methodology, duration and scope.

Enter one of the following:

(1) Pest risk assessment is not required (for those pests referred to in points (a) and (b) of the first paragraph of Article 11, or subject to measures referred to in the second subparagraph of Article 30(1), of Regulation (EU) 2016/2031);

(2) Pest risk assessment, or preliminary pest risk assessment, under development;

(3) Preliminary pest risk assessment exists — outline the major findings, and attach the preliminary pest risk assessment or indicate where it can be found;

(4) Pest risk assessment exists — outline the major findings, and attach the pest risk assessment or indicate where it can be found.

1.1 , 1.3 , 3.1 , 4.1 to 4.4 , 5.1 to 5.6 , 6.1 to 6.7 , 7.1 to 7.6 and 8 must be transmitted to the European and Mediterranean Plant Protection Organisation.

ANNEX II

Common health entry documents (CHEDs)

PART 1

CHED entries and explanatory notes

The entries specified in Part 1 constitute the data dictionaries for the electronic version of the CHED.

Unless otherwise specified or established by Union legislation, all entries or boxes apply to the CHED templates in Part 2.

Paper copies of an electronic CHED must bear a unique machine-readable optical label which hyperlinks to the electronic version.

You shall select one box from boxes I.20 to I.26 and boxes II.9 to II.16; for each box, you shall select one option.

Where a box allows you to select one or more options, only the option(s) you select will be displayed in the electronic version of the CHED.

Where a box is not compulsory, its contents will appear as strike-through text.

The sequences of boxes in the CHED templates in Part 2 and the size and shape of those boxes are indicative.

Where a stamp is required, its electronic equivalent is an electronic seal.

In processing the personal data included in the CHEDs, Member States shall comply with Regulation (EU) 2016/679 and Directive (EU) 2016/680 and the Commission with Regulation (EU) 2018/1725.